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The association between diabetes mellitus (DM) and masked hypertension (MH) in ambulatory blood pressure (BP) monitoring is established, but its relationship with home BP monitoring (HBPM) remains uncertain. This web-based database study compared BP phenotypes in individuals using (n = 51,194; 6.05% with DM) and not using (n = 55,320; 0.63% with DM) antihypertensive medications (AH) undergoing HBPM. Multivariable logistic regression analysis revealed similar MH and white-coat hypertension (WCH) prevalence in individuals with or without DM, irrespective of AH use. However, among AH non-users, DM was associated with a higher likelihood of normotension (OR 1.35, 95%CI 1.09-1.66; p = 0.006) and a lower likelihood of sustained hypertension (OR 0.77, 95%CI 0.60-0.99; p = 0.039) compared to individuals without DM. These findings suggest that while DM does not significantly impact MH and WCH in HBPM, it may influence normotension and sustained hypertension rates in AH non-users. Likelihood of diabetes mellitus according to blood pressure phenotypes. AH - antihypertensive medications; CH - controlled hypertension; MH - masked hypertension; MUCH - masked uncontrolled hypertension; NT - normotension; SH - sustained hypertension; SUCH - sustained uncontrolled hypertension; WCH - white-coat hypertension; WUCH - white-coat uncontrolled hypertension.
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This study investigated the prevalence of white-coat hypertension (WCH) among individuals with office isolated systolic hypertension (ISH), isolated diastolic hypertension (IDH), and systolic-diastolic hypertension (SDH). We evaluated 9122 individuals [57.0 ± 14.5 years, 51% men] with office blood pressure ≥140/90 mmHg who underwent ambulatory blood pressure monitoring (ABPM) and were categorized into younger (<40-years), middle-aged (≥40 and <60-years) and older (≥60-years) groups. The prevalence of WCH in SDH, ISH, and IDH was 18, 61, and 37% in younger, 16, 55, and 29% in middle-aged, and 23, 51, and 40% in older individuals. Multivariable logistic regression analysis showed a higher likelihood of WCH in ISH (4.1, 3.6, and 2.1-fold all p < 0.001) and IDH (1.9, 1.5, and 1.5-fold; all p < 0.001) compared to SDH among younger, middle-aged and older individuals, respectively. These data indicate that ISH and, to a minor extent, IDH are linked to a higher prevalence of WCH derived from ABPM exams.
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OBJECTIVE: Interarm systolic blood pressure difference (IASD) values >15âmmHg (IASD > 15) are associated with increased cardiovascular risk, yet the underlying mechanisms remain unclear. This report evaluated whether IASD >15, assessed by different protocols [sequential or simultaneous; based on one or several blood pressure (BP) readings], was associated with adverse left ventricular (LV) remodeling. METHODS: This cross-sectional study evaluated 605 individuals who underwent clinical and echocardiography evaluation and three pairs of simultaneous arm BP readings. IASD was estimated by seven distinct protocols (three simultaneous and four sequential BP measurements criteria). RESULTS: The cohort had a mean age of 53.5â±â15.4âyears, with 51% being women, 23% with LV hypertrophy, 14% with LV concentricity, 69% with normal geometry, 8% with concentric remodeling, 17% with eccentric hypertrophy and 6% with concentric hypertrophy. Multivariable logistic regression revealed that IASD >15 defined by simultaneous measures of the last two pairs of BP readings (IASDsim2) and sequential arm BP readings (right-left-right arm sequence; IASDseq3) were related to LV concentricity (odds ratio [95% CI]â=â3.24 [1.02-10.28], Pâ=â0.046 and 2.56 [1.09-6.00], Pâ=â0.030, respectively) and LV concentric remodeling (odds ratio [95% CI] â=â4.12 [1.08-15.78], Pâ=â0.039 and 4.16 [1.61-10.76], Pâ=â0.003, respectively). Conversely, IASD >15 defined by any criteria showed no association with LV hypertrophy. CONCLUSION: Individuals with IASD >15 defined by IASDsim2 and IASDseq3 are associated with adverse LV remodeling, namely LV concentricity and LV concentric remodeling. These findings suggest that both criteria might be potentially used to preferentially assess abnormal IASD in the setting of clinical practice.
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AIMS: Patients with aortic dissection have a high prevalence of left ventricular structural alterations, including left ventricular hypertrophy (LVH), but little is known about the impact of sex on this regard. This study compared clinical, cardiac, and prognostic characteristics between men and women with aortic dissection. METHODS: We retrospectively assessed clinical and echocardiographic characteristics, and 1-year mortality in 367 aortic dissection patients (30% women; 66% with Stanford-A) who underwent echocardiography 60âdays before or after the diagnosis of aortic dissection from three Brazilian centers. RESULTS: Men and women had similar clinical characteristics, except for higher age (59.4â±â13.4 vs. 55.9â±â11.6âyears; P â=â0.013) and use of antihypertensive classes (1.4â±â1.3 vs. 1.1â±â1.2; P â=â0.024) and diuretics (32 vs. 19%; P â=â0.004) in women compared with men. Women had a higher prevalence of LVH (78 vs. 65%; P â=â0.010) and lower prevalence of normal left ventricular geometry (20 vs. 10%; P â=â0.015) than men. Logistic regression analysis adjusted for confounding factors showed that women were less likely to have normal left ventricular geometry (odds ratio, 95% confidence intervalâ=â0.42, 0.20-0.87; P â=â0.019) and were more likely to have LVH (odds ratio, 95% confidence intervalâ=â1.91, 1.11-3.27; P â=â0.019). Conversely, multivariable Cox-regression analysis showed that women had a similar risk of death compared to men 1 year after aortic dissection diagnosis (hazard ratio, 95% confidence intervalâ=â1.16, 0.77-1.75; P â=â0.49). CONCLUSION: In aortic dissection patients, women were typically older, had higher use of antihypertensive medications, and exhibited a greater prevalence of LVH compared with men. However, 1-year mortality after aortic dissection diagnosis did not differ between men and women.
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Dissecção Aórtica , Hipertrofia Ventricular Esquerda , Remodelação Ventricular , Humanos , Masculino , Feminino , Dissecção Aórtica/epidemiologia , Dissecção Aórtica/fisiopatologia , Dissecção Aórtica/mortalidade , Pessoa de Meia-Idade , Estudos Retrospectivos , Fatores Sexuais , Idoso , Hipertrofia Ventricular Esquerda/fisiopatologia , Hipertrofia Ventricular Esquerda/epidemiologia , Hipertrofia Ventricular Esquerda/diagnóstico por imagem , Brasil/epidemiologia , Prevalência , Adulto , Fatores de Risco , Ecocardiografia , Aneurisma Aórtico/epidemiologia , Aneurisma Aórtico/mortalidade , Aneurisma Aórtico/diagnóstico por imagem , Aneurisma Aórtico/fisiopatologia , Prognóstico , Fatores de TempoRESUMO
The values used to define white-coat and masked blood pressure (BP) effects are usually arbitrary. This study aimed at investigating the accuracy of various cutoffs based on the differences (ΔBP) between office BP (OBP) and 24h-ambulatory BP monitoring (ABPM) to identify white-coat (WCH) and masked (MH) hypertension, which are phenotypes coupled with adverse prognosis. This cross-sectional study included 11,350 [Derivation cohort; 45% men, mean age = 55.1 ± 14.1 years, OBP = 132.1 ± 17.6/83.9 ± 12.5 mmHg, 24 h-ABPM = 121.6 ± 11.4/76.1 ± 9.6 mmHg, 25% using antihypertensive medications (AH)] and 7220 (Validation cohort; 46% men, mean age = 58.6 ± 15.1 years, OBP = 136.8 ± 18.7/87.6 ± 13.0 mmHg, 24 h-ABPM = 125.5 ± 12.6/77.7 ± 10.3 mmHg; 32% using AH) unique individuals who underwent 24 h-ABPM. We compared the sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) of diverse ΔBP cutoffs to detect WCH (ΔsystolicBP/ΔdiastolicBP = 28/17, 20/15, 20/10, 16/11, 15/9, 14/9 mmHg and ΔsystolicBP = 13 and 10 mmHg) and MH (ΔsystolicBP/ΔdiastolicBP = -14/-9, -5/-2, -3/-1, -1/-1, 0/0, 2/2 mmHg and ΔsystolicBP = -5 and -3mmHg). The 20/15 mmHg cutoff showed the best AUC (0.804, 95%CI = 0.794-0.814) to detect WCH, while the 2/2 mmHg cutoff showed the highest AUC (0.741, 95%CI = 0.728-0.754) to detect MH in the Derivation cohort. Both cutoffs also had the best accuracy to detect WCH (0.767, 95%CI = 0.754-0.780) and MH (0.767, 95%CI = 0.750-0.784) in the Validation cohort. In secondary analyses, these cutoffs had the best accuracy to detect individuals with higher and lower office-than-ABPM grades in both cohorts. In conclusion, the 20/15 and 2/2 mmHg ΔBP cutoffs had the best accuracy to detect hypertensive patients with WCH and MH, respectively, and can serve as indicators of marked white-coat and masked BP effects derived from 24 h-ABPM.
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Monitorização Ambulatorial da Pressão Arterial , Pressão Sanguínea , Hipertensão Mascarada , Hipertensão do Jaleco Branco , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Hipertensão do Jaleco Branco/diagnóstico , Hipertensão do Jaleco Branco/fisiopatologia , Hipertensão Mascarada/diagnóstico , Hipertensão Mascarada/fisiopatologia , Estudos Transversais , Idoso , Adulto , Valor Preditivo dos Testes , Reprodutibilidade dos TestesRESUMO
BACKGROUND: The Covid-19 pandemic has affected patients with end-stage kidney disease (ESKD). Whether dialysis parameters have a prognostic value in ESKD patients with Covid-19 remains unclear. MATERIALS AND METHODS: We retrospectively evaluated clinical characteristics, blood pressure (BP) and dialysis parameters in ESKD patients undergoing maintenance outpatient hemodialysis, with (Covid-ESKD) and without (No-Covid-ESKD) Covid-19, at four Brazilian hemodialysis facilities. The Covid-ESKD (n = 107; 54% females; 60.8 ± 17.7 years) and No-Covid-ESKD (n = 107; 62% females; 58.4 ± 14.6 years) groups were matched by calendar time. The average BP and dialysis parameters were calculated during the pre-infection, acute infection, and post-infection periods. The main outcomes were Covid-19 hospitalization and all-cause mortality. RESULTS: Covid-ESKD patients had greater intradialytic and postdialysis systolic BP and lower predialysis weight, postdialysis weight, ultrafiltration rate, and interdialytic weight gain during acute-illness compared to 1-week-before-illness, while these changes were not observed in No-Covid-ESKD patients. After 286 days of follow-up (range, 276-591), there were 18 Covid-19-related hospitalizations and 28 deaths among Covid-ESKD patients. Multivariable logistic regression analysis showed that increases in predialysis systolic BP from 1-week-before-illness to acute-illness (OR, 95%CI = 1.06, 1.02-1.10; p = .004) and Covid-19 vaccination (OR, 95%CI = 0.16, 0.04-0.69; p = .014) were associated with hospitalization in Covid-ESKD patients. Multivariable Cox-regression analysis showed that Covid-19-related hospitalization (HR, 95%CI = 5.17, 2.07-12.96; p < .001) and age (HR, 95%CI = 1.05, 1.01-1.08; p = .008) were independent predictors of all-cause mortality in Covid-ESKD patients. CONCLUSION: Acute Covid-19 illness is associated with variations in dialysis parameters of volume status in patients with ESKD. Furthermore, increases in predialysis BP during acute Covid-19 illness are associated with an adverse prognosis in Covid-ESKD patients.
Dialysis parameters were influenced by SARS-CoV-2 infection and may have prognostic value in patients with Covid-19.Increases in blood pressure during acute Covid-19 illness and the lack of vaccination for Covid-19 were predictors of hospitalization for Covid-19.Hospitalization for Covid-19 and age were independent risk factors for all-cause death.
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COVID-19 , Falência Renal Crônica , Diálise Renal , SARS-CoV-2 , Humanos , COVID-19/complicações , COVID-19/mortalidade , COVID-19/epidemiologia , COVID-19/terapia , Feminino , Pessoa de Meia-Idade , Masculino , Falência Renal Crônica/terapia , Falência Renal Crônica/complicações , Falência Renal Crônica/mortalidade , Falência Renal Crônica/epidemiologia , Diálise Renal/estatística & dados numéricos , Estudos Retrospectivos , Prognóstico , Idoso , Brasil/epidemiologia , Adulto , Hospitalização/estatística & dados numéricos , Pressão SanguíneaRESUMO
Introduction: Hypertension (HT) remains the leading cause of death worldwide. In Brazil it is estimated that 35% of the adult population has HT and that about 20% of these have blood pressure values within the targets recommended for the reduction of cardiovascular risk. There are some data that point to different control rates in patients treated by cardiologists in public and private referral center and this is an important point to be investigated and discussed. Objective: To compare sociodemographic characteristics, body mass index (BMI), antihypertensive (AH) drugs, blood pressure (BP) and control rate in public (PURC) and private (PRRC) referral centers. Methodology: A cross-sectional multicenter study that analyzed data from hypertensive patients assisted by the PURC (one in Midwest Region and other in Northeast region) and PRRC (same distribution). Variables analyzed: sex, age, BMI, classes, number of AH used and mean values of systolic and diastolic BP by office measurement and home blood pressure measurement (HBPM). Uncontrolled hypertension (HT) phenotypes and BP control rates were assessed. Descriptive statistics and χ2 tests or unpaired t-tests were performed. A significance level of p < 0.05 was considered. Results: A predominantly female (58.9%) sample of 2.956 patients and a higher prevalence of obesity in PURC (p < 0.001) and overweight in PRRC (p < 0.001). The mean AH used was 2.9 ± 1.5 for PURC and 1.4 ± 0.7 for PRRC (p < 0.001). Mean systolic and diastolic BP values were higher in PURC as were rates of uncontrolled HT of 67.8% and 47.6% (p < 0.001) by office measurement and 60.4% and 35.3% (p < 0.001) by HBPM in PURC and PRRC, respectively. Conclusion: Patients with HT had a higher prevalence of obesity in the PURC and used almost twice as many AH drugs. BP control rates are worse in the PURC, on average 15.3â mmHg and 12.1â mmHg higher than in the PRRC by office measurement.
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This study compared the ability of guideline-proposed office blood pressure (OBP) screening thresholds [European Society of Hypertension (ESH) guidelines: 130/85 mmHg for individuals with an OBP < 140/90 mmHg; American College of Cardiology/American Heart Association (ACC/AHA) guidelines: 120/75 mmHg for individuals with an OBP < 130/80 mmHg] and novel screening scores to identify normotensive individuals at high risk of having masked hypertension (MH) in an office setting. We cross-sectionally evaluated untreated participants with an OBP < 140/90 mmHg (n = 22,266) and an OBP < 130/80 mmHg (n = 10,005) who underwent home blood pressure monitoring (HBPM) (derivation cohort) from 686 Brazilian sites. MH was defined according to criteria suggested by the ESH (OBP < 140/90 mmHg; HBPM ≥ 135/85 mmHg), Brazilian Society of Cardiology (BSC) (OBP < 140/90 mmHg; HBPM ≥ 130/80 mmHg) and ACC/AHA (OBP < 130/80 mmHg; HBPM ≥ 130/80 mmHg). Scores were generated from multivariable logistic regression coefficients between MH and clinical variables (OBP, age, sex, and BMI). Considering the ESH, BSC, and ACC/AHA criteria, 17.2%, 38.5%, and 21.2% of the participants had MH, respectively. Guideline-proposed OBP screening thresholds yielded area under curve (AUC) values of 0.640 (for ESH criteria), 0.641 (for BSC criteria), and 0.619 (for ACC/AHA criteria) for predicting MH, while scores presented as continuous variables or quartiles yielded AUC values of 0.700 and 0.688 (for ESH criteria), 0.720 and 0.709 (for BSC criteria), and 0.671 and 0.661 (for ACC/AHA criteria), respectively. Further analyses performed with alternative untreated participants (validation cohort; n = 2807 with an OBP < 140/90 mmHg; n = 1269 with an OBP < 130/80 mmHg) yielded similar AUC values. In conclusion, the accuracy of guideline-proposed OBP screening thresholds in identifying individuals at high risk of having MH in an office setting is limited and is inferior to that yielded by scores derived from simple clinical variables.
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Hipertensão , Hipertensão Mascarada , Estados Unidos , Humanos , Hipertensão Mascarada/diagnóstico , Monitorização Ambulatorial da Pressão Arterial , Pressão Sanguínea , Determinação da Pressão ArterialRESUMO
Background: Previous Randomised controlled trials (RCT) evaluating chloroquine and hydroxychloroquine in non-hospitalised COVID-19 patients have found no significant difference in hospitalisation rates. However, low statistical power precluded definitive answers. Methods: We conducted a multicenter, double-blind, RCT in 56 Brazilian sites. Adults with suspected or confirmed COVID-19 presenting with mild or moderate symptoms with ≤ 07 days prior to enrollment and at least one risk factor for clinical deterioration were randomised (1:1) to receive hydroxychloroquine 400 mg twice a day (BID) in the first day, 400 mg once daily (OD) thereafter for a total of seven days, or matching placebo. The primary outcome was hospitalisation due to COVID-19 at 30 days, which was assessed by an adjudication committee masked to treatment allocation and following the intention-to-treat (ITT) principle. An additional analysis was performed only in participants with SARS-CoV-2 infection confirmed by molecular or serology testing (modified ITT [mITT] analysis). This trial was registered at ClinicalTrials.gov, NCT04466540. Findings: From May 12, 2020 to July 07, 2021, 1372 patients were randomly allocated to hydroxychloroquine or placebo. There was no significant difference in the risk of hospitalisation between hydroxychloroquine and placebo groups (44/689 [6·4%] and 57/683 [8·3%], RR 0·77 [95% CI 0·52-1·12], respectively, p=0·16), and similar results were found in the mITT analysis with 43/478 [9·0%] and 55/471 [11·7%] events, RR 0·77 [95% CI 0·53-1·12)], respectively, p=0·17. To further complement our data, we conducted a meta-analysis which suggested no significant benefit of hydroxychloroquine in reducing hospitalisation among patients with positive testing (69/1222 [5·6%], and 88/1186 [7·4%]; RR 0·77 [95% CI 0·57-1·04]). Interpretation: In outpatients with mild or moderate forms of COVID-19, the use of hydroxychloroquine did not reduce the risk of hospitalisation compared to the placebo control. Our findings do not support the routine use of hydroxychloroquine for treatment of COVID-19 in the outpatient setting. Funding: COALITION COVID-19 Brazil and EMS.
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This study aimed at comparing the prevalence of abnormal blood pressure (BP) phenotypes among 241 adolescents referred for hypertension (15.4 ± 1.4 years, 62% males, 40% obese) according to mostly used or available criteria for hypertension [AAP or ESH criteria for high office BP (OBP); Arsakeion or Goiânia schools' criteria for high home BP monitoring (HBPM)]. High OBP prevalence was greater when defined by AAP compared with ESH criteria (43.5% vs. 24.5%; p < .001), while high HBPM prevalence was similar between Arsakeion and Goiânia criteria (33.5% and 37.5%; p = .34). Fifty-five percent of the sample fulfilled at least one criterion for high BP, but only 31% of this subsample accomplished all four criteria. Regardless of the HBPM criteria, AAP thresholds were associated with lower prevalence of normotension and masked hypertension and greater prevalence of white-coat and sustained hypertension than ESH thresholds. These findings support the need to standardize the definition of hypertension among adolescents.
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Hipertensão , Hipertensão Mascarada , Hipertensão do Jaleco Branco , Adolescente , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Feminino , Humanos , Hipertensão/diagnóstico , Hipertensão/epidemiologia , Masculino , Hipertensão Mascarada/diagnóstico , Hipertensão Mascarada/epidemiologia , Prevalência , Hipertensão do Jaleco Branco/diagnóstico , Hipertensão do Jaleco Branco/epidemiologiaRESUMO
There are concerns that hypertension control may decrease during the COVID-19 pandemic. This study evaluated the impact of the COVID-19 pandemic on office blood pressure (OBP) and home blood pressure monitoring (HBPM) control in a large Brazilian nationwide sample. The results of an adjusted spline analysis evaluating the trajectory of OBP and HBPM control from 01/Jan/2019 to 31/Dec/2020 among independent participants who were untreated (n = 24,227) or treated (n = 27,699) with antihypertensive medications showed a modest and transient improvement in OBP control among treated individuals, which was restricted to the early months following the COVID-19 pandemic outbreak. Furthermore, slight reductions in OBP and HBPM values were detected in the early months following the COVID-19 pandemic outbreak among treated (n = 987) participants for whom blood pressure measurements before and during the pandemic were available, but not among untreated (n = 495) participants. In conclusion, we found no major adverse influence of the COVID-19 pandemic on OBP and HBPM control in a large nationwide sample.
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COVID-19 , Hipertensão , Pressão Sanguínea , Monitorização Ambulatorial da Pressão Arterial , Humanos , Hipertensão/diagnóstico , Hipertensão/tratamento farmacológico , Hipertensão/epidemiologia , Pandemias , SARS-CoV-2RESUMO
A hipertensão arterial (HA) é o principal fator contributivo para as doenças cardiovasculares, as quais constituem a mais importante causa de morte prevenível no mundo. A falta de conhecimento da população acerca da doença, e consequentemente de um diagnóstico adequado, torna baixo o número de pessoas que se tratam. O aspecto silencioso da HA, e a má adesão ao tratamento proposto, dentre outros fatores, contribuem para o elevado risco de complicações. A medida da pressão arterial (PA) neste contexto apresenta grande importância não apenas no diagnóstico, mas também no acompanhamento de portadores de HA, podendo ser realizada de forma casual, em consultório, ou fora do mesmo com a utilização de outros métodos para tal. Dentre as medidas de PA, a monitorização residencial da PA (MRPA) se destaca. É um método destinado a fazer registro da PA fora do ambiente de consultório, obedecendo a um protocolo previamente estabelecido e normatizado. Além disto, a MRPA apresenta custos menores do que a monitorização ambulatorial da PA (MAPA). De acordo com a atual Diretriz Brasileira de HA, são considerados anormais valores de PA consultório ≥ 140/90 mmHg e de MRPA ≥ 130/80 mmHg. Sob esta perspectiva, a MRPA é um exame que permite que se faça o diagnóstico de HA verdadeira (PA elevada no consultório e na MRPA), normotensão verdadeira (PA normal no consultório e na MRPA), HA do avental branco (HAB) (PA elevada no consultório e normal na MRPA) e HA mascarada (HM) (PA normal no consultório e elevada na MRPA). O diagnóstico de HM é bastante relevante na prática clínica, pois em termos prognósticos, a HM apresenta um risco cardiovascular maior que a HAB e a normotensão verdadeira. Além disto, a incidência de eventos cardiovasculares na HM é similar ou até superior à da HA verdadeira.
Hypertension is the main contributing factor to cardiovascular diseases, which are the most important cause of death in the world. The lack of proper diagnosis, mainly due to the silent aspect of hypertension, makes the rate of people undergoing treatment low, contributing to the high risk of complications. The measurement of blood pressure (BP) in this context is important not only in the diagnosis, but also in the follow-up of patients with hypertension, and it can be performed casually, in the office, or outside the office, using other methods for this purpose. Home blood pressure monitoring (HBPM) is a method designed to record BP outside the office environment, following a previously established and standardized protocol and has a lower cost than ambulatory blood pressure monitoring (ABPM) According to the current Brazilian hypertension guideline, office BP values ≥ 140/90 mmHg and HBPM values ≥ 130/80 mmHg are considered abnormal. From this perspective, HBPM is a test that allows the diagnosis of true hypertension (high BP in the office and in HMBP), true normotension (normal BP in the office and in the HBPM), white coat hypertension (high BP in the office and normal BP in HBPM) and masked hypertension (normal BP in the office and high in HBPM). The diagnosis of masked hypertension is quite relevant in clinical practice, because this phenotype has greater cardiovascular risk than true normotension and white coat hypertension. On the other hand, the incidence of cardiovascular events is similar or even greater in masked hypertension in comparison with true hypertension.
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Humanos , Monitorização Ambulatorial da Pressão Arterial , Fatores de Risco de Doenças Cardíacas , Hipertensão/diagnóstico , Hipertensão/prevenção & controleRESUMO
BACKGROUND: COVID-19 can lead to multiorgan failure. Dapagliflozin, a SGLT2 inhibitor, has significant protective benefits for the heart and kidney. We aimed to see whether this agent might provide organ protection in patients with COVID-19 by affecting processes dysregulated during acute illness. METHODS: DARE-19 was a randomised, double-blind, placebo-controlled trial of patients hospitalised with COVID-19 and with at least one cardiometabolic risk factor (ie, hypertension, type 2 diabetes, atherosclerotic cardiovascular disease, heart failure, and chronic kidney disease). Patients critically ill at screening were excluded. Patients were randomly assigned 1:1 to dapagliflozin (10 mg daily orally) or matched placebo for 30 days. Dual primary outcomes were assessed in the intention-to-treat population: the outcome of prevention (time to new or worsened organ dysfunction or death), and the hierarchial composite outcome of recovery (change in clinical status by day 30). Safety outcomes, in patients who received at least one study medication dose, included serious adverse events, adverse events leading to discontinuation, and adverse events of interest. This study is registered with ClinicalTrials.gov, NCT04350593. FINDINGS: Between April 22, 2020 and Jan 1, 2021, 1250 patients were randomly assigned with 625 in each group. The primary composite outcome of prevention showed organ dysfunction or death occurred in 70 patients (11·2%) in the dapagliflozin group, and 86 (13·8%) in the placebo group (hazard ratio [HR] 0·80, 95% CI 0·58-1·10; p=0·17). For the primary outcome of recovery, 547 patients (87·5%) in the dapagliflozin group and 532 (85·1%) in the placebo group showed clinical status improvement, although this was not statistically significant (win ratio 1·09, 95% CI 0·97-1·22; p=0·14). There were 41 deaths (6·6%) in the dapagliflozin group, and 54 (8·6%) in the placebo group (HR 0·77, 95% CI 0·52-1·16). Serious adverse events were reported in 65 (10·6%) of 613 patients treated with dapagliflozin and in 82 (13·3%) of 616 patients given the placebo. INTERPRETATION: In patients with cardiometabolic risk factors who were hospitalised with COVID-19, treatment with dapagliflozin did not result in a statistically significant risk reduction in organ dysfunction or death, or improvement in clinical recovery, but was well tolerated. FUNDING: AstraZeneca.
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Compostos Benzidrílicos/administração & dosagem , COVID-19/complicações , Fatores de Risco Cardiometabólico , Glucosídeos/administração & dosagem , Insuficiência de Múltiplos Órgãos/prevenção & controle , Inibidores do Transportador 2 de Sódio-Glicose/administração & dosagem , Idoso , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência de Múltiplos Órgãos/complicações , Resultado do TratamentoRESUMO
This study investigated the impact of changing abnormal home blood pressure monitoring (HBPM) cutoff from 135/85 to 130/80 mmHg on the prevalence of hypertension phenotypes, considering an abnormal office blood pressure cutoff of 140/90 mmHg. We evaluated 57 768 individuals (26 876 untreated and 30 892 treated with antihypertensive medications) from 719 Brazilian centers who performed HBPM. Changing the HBPM cutoff was associated with increases in masked (from 10% to 22%) and sustained (from 27% to 35%) hypertension, and decreases in white-coat hypertension (from 16% to 7%) and normotension (from 47% to 36%) among untreated participants, and increases in masked (from 11% to 22%) and sustained (from 29% to 36%) uncontrolled hypertension, and decreases in white-coat uncontrolled hypertension (from 15% to 8%) and controlled hypertension (from 45% to 34%) among treated participants. In conclusion, adoption of an abnormal HBPM cutoff of 130/80 mmHg markedly increased the prevalence of out-of-office hypertension and uncontrolled hypertension phenotypes.